Kornimate/medical-research-clean huggingface dataset:
viome precision nutritional programs to improve clinical outcomes for mental health disorders

Conditions: Mental Health Issue; Depression; Anxiety

Summary: us residents who have mental health issues sign the informed consent form and are screened and enrolled for this study. participants complete a survey upon enrollment and are randomized into one of two study arms. this study is direct to participant and will not utilize clinical sites.

participants who meet the eligibility criteria are randomized into any of the two study arms including: the placebo arm or the viome precision nutrition program (vpnp) arm. placebo and viome's precision nutrition program include supplements, may include dietary recommendations towards improving the symptoms associated with mental health. the trial will last approximately 4 months for each participant.

Eligibility criteria:
inclusion criteria: * resident of the united states * females and males ages 25-75 (inclusive) * able to speak and read english * no unexplained weight loss, fevers, anemia, or blood in stool * willing and able to follow the trial instructions, as described in the recruitment letter * signed and dated informed consent prior to any trial-specific procedures. * phq9 score of 5-24 (inclusive) exclusion criteria: * unwilling to change their current diet * prior use of viome products or services * antibiotic use in the previous 4 weeks * pregnancy (current or planned in the next 4 months) * \< 90 days postpartum * breast feeding * active infection * unable or unwilling to use viome's app on an iphone or android smartphone * significant diet or lifestyle change in the previous 1 month * ibd diagnosis -major psychiatric/dsm-4 disease diagnosis (e.g. schizophrenia, bipolar disorder, post- traumatic stress disorder, obsessive compulsive disorder) * use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial * cancer therapy within the previous 1 year * major surgery in the last 6 months or planned in the next 4 months * allergies to any supplement ingredients listed in the screening survey * currently on a specific diet: fodmap, keto, paleo * answered yes to the question, "in the past few weeks, have you wished you were dead or had thoughts about killing yourself?" * gastrointestinal disease including: * gi surgery except: * appendectomy and benign polypectomy * esophagitis * celiac disease * gi malignancy or obstruction * peptic ulcer disease * duodenal or gastric ulcer disease

Keywords: mental health diet supplements vitamins stress
using a preparation and education intervention to reduce postpartum depression among new mothers (the made it 2 study)

Conditions: Depression, Postpartum; Depression

Summary: this study will test an intervention that aims to prevent postpartum depression by providing new mothers with information on and resources for dealing with the disorder.

postpartum depression (ppd) is a disorder affecting many women after delivery of a child. up to 50% of mothers may experience some depressive symptoms after giving birth, and up to 25% of them will develop major depressive disorder. some situational factors that place mothers at risk of ppd may be changed or minimized, including social support, the mother's efficiency in handling situational stress, and distress from physical symptoms. preparing mothers to identify potential situational triggers of depressive symptoms, enhancing their postpartum self-management skills, and providing them access to the proper social and healthcare resources may prevent them from developing major depression. this study will test the efficacy of a brief intervention that aims to prevent ppd by preparing mothers to deal with stressful triggers and depressive symptoms. this study will last 6 months. participants will be randomly assigned to receive either treatment as usual or the behavioral education intervention. the intervention will involve two parts. first, after giving birth and while still in the hospital, participants will complete an education session with a social worker and receive written materials about ppd. then, 2 weeks after discharge from the hospital, participants will receive a call from the social worker, who will conduct a needs assessment that addresses participants' physical and emotional health. if a participant is experiencing distress, the social worker will refer her to appropriate resources and will reinforce self-management skills. all participants will receive a list of community and hospital resources by mail. study assessments will take place at 3 weeks, 3 months, and 6 months after study entry. at these points, participants will complete a 20-minute phone survey with a research assistant about their health, mood, and basic demographic information.

Eligibility criteria:
inclusion criteria: * patient in the maternity unit at mount sinai hospital * infant has a birth weight greater than or equal to 2,500 grams * infant has a 5-minute apgar score greater than or equal to 7 * self-identifies as white or minority other than black or hispanic; black and hispanic women will be referred to a parallel study with the same protocol at mount sinai hospital * speaks english * has a working telephone

Keywords: postpartum depressive symptoms physical symptoms emotional symptoms infant colic social support breastfeeding
study to evaluate investigational allogeneic cell therapy product homsc300 for treatment of early to moderate stage multiple system atrophy (msa)

Conditions: Multiple System Atrophy; MSA - Multiple System Atrophy

Summary: purpose of this phase 1 study is to assess the safety of intrathecal administration of allogeneic human oral mucosa stem cells (homscs) in patients suffering from early to moderate stage multiple system atrophy (msa)


Eligibility criteria:
inclusion criteria: * patient was diagnosed with probable msa-c (cerebellar) or msa-p (parkinsonian) variant within 60 months of symptom onset (excluding impotence) * subject can ambulate without the assistance of another person, defined as the ability to take at least 10 steps. use of assistive devices is allowed * patient cognitive state permits him to sign informed consent, according to the pi's clinical judgement, and moca \>= 24 exclusion criteria: * pregnant women and women before menopause * participants with a clinically significant or unstable medical or surgical condition that, in the opinion of the investigator, might preclude safe completion of the treatment or affect the treatment outcome. * patients with thrombocytopenia, other bleeding diathesis or taking anticoagulant therapy (not including aspirin up to 100mg per day) * patients with known hypersensitivities to plasmalyte, gadolinium, penicillin, and with general hypersensitivity to antibiotics * patients who fulfill the criteria of parkinson's disease * history of electroconvulsive therapy * history of brain surgery

Keywords: multiple system atrophy msa stem cells intrathecal
antipyretics for preventing recurrences of febrile seizures

Conditions: Recurrence of Febrile Seizure

Summary: we wanted to find out if the early use of antipyretics is capable in preventing recurrences of febrile seizures. when a child has had his/her first febrile seizure, the parents were instructed to give him/her antipyretic medication every time when the child had a new episode of fever during two years.


Eligibility criteria:
inclusion criteria: * first febrile convulsion exclusion criteria: * any prior convulsion or antiepileptic medication
validation of "escala de conductas indicadoras de dolor" escid scale for measuring pain in critically ill patients

Conditions: Pain

Summary: pain is an unpleasant and important stress factor, and a potentially harmful experience for critically ill patients. pain is harder to evaluate in non-communicative patients, who can´t report their own pain. behavioral indicators have been proved as useful and reliable for detecting and measuring pain in these patients, and have been the basis for constructing scales for measuring pain, such as the behavioural pain scale (bps), the critical care observation tool (cpot) and the scale of behaviors indicating pain (escid) . the bps and escid were tested in a study with a sample of 42 critically ill patients in spain, showing good validity and reliability. the objective of this spanish multicentre study is to test the validity and reliability of the escid scale in a large sample of critically ill patients with medical and postsurgical pathology for the detection and measurement of pain.

the specific aims for the study are : to determine the validity and reliability of the escid scale to assess pain in non-communicative critically ill patients on mechanical ventilation, in a large sample of critically ill medical and surgical patients. to assess the relationship between the application of a common and painful procedure, usual in daily practice, and its associated changes in physiological indicators of pain: variation of heart rate, blood pressure, respiratory rate, sweating. to assess the degree of pain when applying two painful procedures documented as common in the usual care of critically ill patients, and one non-painful procedure, using two pain scales: escid and bps. to assess the differences in the employment of the pain scales in patients with medical and surgical pathology.

Eligibility criteria:
inclusion criteria: * patient must be 18 years of age or older * patient's primary language spanish where the evaluation is performed * patient meets irb/central ec requirements of the institution/ country where the evaluation is performed * patient is receiving the study's procedures as part of standard care, excepting the non painful procedure exclusion criteria: * patient's condition is very unstable at the time of measurement of pain * patient is receiving neuromuscular blocking medications at the time of measurement of pain * patient´s probable or diagnosed delirium

Keywords: pain mechanical ventilation uncommunicative adult icu patients pain
a trial of shr-1701 in combination with gemcitabine and albumin paclitaxel in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the study is being conducted to evaluate the efficacy, safety and tolerability of shr-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the rp2d for shr-1701 in the combined regimen.


Eligibility criteria:
inclusion criteria: * male or female subjects aged between 18 and 70 years; * life expectancy ≥ 12 weeks judged by the investigator. * the ecog performance status was 0-1. * at least 1 measurable lesion conforming to recist 1.1 criteria. * in subjects with histologically or cytologically confirmed pancreatic cancer, there was evidence of inoperable locally advanced or distant metastases. * adequate organ and bone marrow function. * female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; for male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study. * willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures. exclusion criteria: * known allergy to the study drug or any of its excipients; or had a serious allergic reaction to other monoclonal antibodies. * previous exposure to drugs/antibodies acting on t cell co-stimulation or checkpoint pathways. * major surgery within 28 days before the first experimental treatment (biopsy required for diagnosis is permitted). * subject with central nervous system (cns) metastases. * had other active malignant tumors within 5 years before entering the study. except for basal cell or squamous cell carcinomas, superficial bladder carcinomas, carcinoma in situ of the cervix, ductal carcinoma in situ, and papillary carcinoma of the thyroid, which may be treated locally and have been cured. * human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome (aids), untreated active hepatitis. * the presence of clinically significant acute or chronic pancreatitis. * the presence of other acute or chronic infections of clinically significant significance. * history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
patient-caregiver communication intervention for prognostic understanding

Conditions: Advanced Cancer

Summary: the purpose of this study is to: (1) develop a communication-based intervention to improve advanced cancer patients' and caregivers' prognostic understanding using communication strategies (e.g., acknowledgment, validation of fears) and distress management techniques (e.g., deep breathing, muscle relaxation); (2) evaluate the feasibility and acceptability of the intervention among advanced cancer patients and their caregivers; and (3) test the preliminary efficacy of the intervention on patients' and caregivers' prognostic understanding (primary outcome); completion of dnr order, living will, and health care proxy; psychological distress; communication quality; caregiver burden; and healthcare utilization (secondary outcomes).


Eligibility criteria:
patient inclusion criteria: * diagnosis of poor prognosis advanced cancer defined as locally advanced or metastatic cancer (e.g., pancreaticobiliary, esophagogastric, hepatocellular carcinoma, lung, or gynecological cancer) and/or disease progression following at least first line chemotherapy. * ability to provide informed consent * identification of an informal caregiver * oncologist reported discussion of prognosis with the patient and/or caregiver. patient exclusion criteria: * not fluent in english * severely cognitively impaired (as measured by short portable mental status questionnaire scores of \< 6) * too ill or weak to complete the interviews (as judged by the interviewer) * currently receiving palliative care/hospice at the time of enrollment * children and young adults under age 18 * deemed inappropriate for the study by their treating oncologist. * in addition, patient-caregiver dyads in which both members have an accurate understanding of prognosis (terminal status and life-expectancy) will be excluded due to the lack of need for an intervention. caregiver inclusion criteria: * the person (family member or friend) whom the patient indicates provides their informal (unpaid) care * english speaking * able to provide informed consent

Keywords: advance care planning prognostic understanding communication
using peer mentors to support pact team efforts to improve diabetes control

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to test the effectiveness of a peer mentor model in a mixed race population of poorly controlled diabetic veterans. also, the study aims to assess the effects of becoming a mentor on those who originally were mentees. it is expected that participants in the peer mentoring arms (arm 2 and 3) will have improved glucose control regardless of race or ethnicity at the end of the intervention.

the primary objectives of this study are: (1) test the long-term effectiveness of a peer mentor model on improving glucose control, blood pressure, ldl levels, diabetes mellitus quality of life, and depression scores in a mixed race population of poorly controlled diabetic veterans; (2) test the effectiveness of using former peer mentees as peer mentors as a means of creating a self-sustaining program; and (3) and test the effects of becoming a mentor on those who were originally mentees given a growing literature that being a mentor is good for your health. secondary objectives include: (1) in those randomized to being a mentee, explore mentor characteristics associated with improved hba1c. this study will be a prospective randomized controlled trial. outcomes to be measured include glycosylated hemoglobin, blood pressure, direct ldl, diabetes quality of life and depression. the trial has two phases. in phase one, patients with poorly controlled diabetes are randomized to usual care or receiving peer mentoring. in phase two, poorly controlled diabetics are randomized to usual care or receiving peer mentoring from former mentees. former mentees from phase 1 are also randomized such that they will have a 50% chance of becoming a mentor.

Eligibility criteria:
inclusion criteria: inclusion criteria: * all participants must have a diagnosis of type 2 diabetics. * diabetes began after age 30 * mentees: have an hba1c \> 8% on 2 different occasions in the course of 24 months, with at least one measure within 3 months of enrollment * mentors for phase 1: had an hba1c of \> 8% in the past 3 years and an hba1c \< (or equal to) 7.5% within 3 months of enrollment * mentors for phase 2: former mentee exclusion criteria: exclusion criteria: * does not speak english * unable to understand consents * severe speech impediment * over the age of 75

Keywords: diabetes mellitus mentors glucose control hemoglobin a, glycosylated randomized controlled trial veterans
effects of left ventricular assist device implantation on the phenotype of blood platelets and leucocytes

Conditions: Cardiac Insufficiency

Summary: to compare in vivo platelet and leukocyte activation and phenotype before and after left ventricular assist device (lavd) implantation

the present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. as one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. these parameters will be compared at 3 time-points, before and after lavd implantation in ambulatory patients.

Eligibility criteria:
inclusion criteria: * elective implantation of lavd (heartmate ii), * written informed consent to the study * patients with health insurance exclusion criteria: * treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed). * pregnancy or breastfeeding * juridical protection

Keywords: left ventricular assist device platelet-leukocyte conjugates lipo-oxygenase products
comparison of three different prophylactic treatments of postoperative nausea and vomiting (ponv) in children

Conditions: Postoperative Nausea and Vomiting

Summary: incidence of postoperative nausea and vomiting (ponv) in children after tonsillectomy with or without adenoidectomy may be as high as 75%. several medications may prevent and treat ponv, such as steroids, antidopaminergic drugs and serotonin (5-ht3) antagonists. the objective of this study is to compare three prophylactic antiemetic treatments: * dexamethasone alone (250 mcg/kg) * dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg) * dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (ponv). causes are principally trigeminal nerve stimulation and presence of blood in the stomach. consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. more barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances. several medications may prevent and treat ponv, such as steroids, antidopaminergic drugs and serotonin (5-ht3) antagonists. the objective of this study is to compare three prophylactic antiemetic treatments: * dexamethasone alone (250 mcg/kg) * dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg) * dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg). the hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.

Eligibility criteria:
inclusion criteria: * children aged 2-10 y. * children asa 1-2 * weight \> 15 kg * tonsillectomy with or without adenoidectomy exclusion criteria: * intravenous induction * contraindication to steroids * contraindication to antidopaminergic drugs * contraindication to serotoninergic antagonists * administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery * refusal of parents * no-french speaking parents

Keywords: ponv dexamethasone droperidol ondansetron tonsillectomy
echocardiographic assessment of the impact of diabetes and prognostic analysis of heart transplantation

Conditions: Heart Transplant

Summary: the aim of this study is to evaluat the impact of diabetes on cardiac function in patients with heart transplantation by multimodal imaging and analyse their prognosis.

this study is planed to enroll 300000 patients after heart transplantation, all the patients will be divided into 3 groups according to whether or not they have diabetes and when did they develop diabete. echocardiography will be used to evaluat their cardiac function. comparing their cardiac function and clinical information and analysing their prognosis to evaluat the impact of diabetes.

Eligibility criteria:
inclusion criteria: * adult patients who received a heart transplant after 2015 exclusion criteria: * the image quality is poor
screening for primary ciliary dyskinesia using nasal nitric oxide

Conditions: Primary Ciliary Dyskinesia

Summary: background: primary ciliary dyskinesia (pcd) is a rare genetic disease characterised by recurrent respiratory infections and subfertility due to dysfunction of cilia (brushes) of the lining cells. undiagnosed and untreated it can result in an irreversible crippling chronic lung disease. the diagnosis of pcd is a difficult one and involves the complex assessment of ciliary structure and function. thus, pcd is under diagnosed and appropriate preventative and symptomatic treatment may be denied in many patients. in addition, the gene responsible for pcd is at present unknown, thus preventing pre-natal diagnosis and genetic counseling. working hypothesis and aims: recently, it has become apparent that the evaluation of nasally expired nitric oxide (no) constitutes a simple and non-invasive diagnostic method, which discriminates between pcd patients, pcd carriers and healthy controls at high rate of specificity and sensitivity. testing is simple and last approximately one minute. we have recently identified a unique isolated druze population with high prevalence of pcd. the high frequency of disease places this closed community at a high risk of undiagnosed pcd. the aim of this project is to use nasal no measurement as a screening tool to identify possible undiagnosed cases of pcd and pcd carriers in this high risk druze population.


Eligibility criteria:
inclusion criteria: * voluntary willing to participate exclusion criteria: * recent urti * steroids use 2 weeks prior to testing